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India approves two Covid vaccines for emergency use

NEWS DELHI, January 3, 2021

India has approved two coronavirus vaccines for emergency use both 'Made in India', in a major step toward halting the spread of the coronavirus in one of the world’s hardest-hit countries.
 
The first one, Covishield has been developed by AstraZeneca and Oxford University in partnership with Pune-based Serum Institute of India and the other Covaxin is indegeniously developed by the country's Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
 
A government minister said earlier the AstraZeneca/Oxford vaccine had been given the green light on Friday, paving the way for a huge immunisation campaign in the world’s second most populous country. 
 
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a Covid-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
 
Announcing this at a news conference in New Delhi on Sunday, Dr VG Somani, the drugs controller general of India, said the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech came after “careful examination” of both by the c, India’s pharmaceutical regulator.
 
Prime Minister Narendra Modi on Sunday said approval to the vaccines of AstraZeneca-Oxford, being manufactured in India by Serum Institute of India (SII), and Bharat Biotech Ltd “accelerates the road to a healthier and Covid-free nation”,
 
His tweet came minutes after the Drugs Controller General of India (DCGI) nod for the two shots for emergency use.
 
Somani said the overall efficacy of the AstraZeneca-Oxford vaccine was 70.42% and that of Bharat Biotech’s Covaxin was “safe and provides a robust immune response”. “We will never approve anything if there is slightest of safety concern. The vaccines are 100% safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” he added.
 
The Prime Minister also, in a series of tweet, expressed gratitude to the frontline workers involved in the fight against the coronavirus pandemic.
 
“A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” PM Modi tweeted. 
 
“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” he stated.
 
'Will Help Intensify Fight Against Covid': WHO Welcomes India's Vaccine Approval
The approval paves the way for the roll out of at least two vaccines in India in the coming days.
 
The World Health Organisation has welcomed India's decision to give emergency use authorisation to two Covid-19 vaccines, saying it will "help intensify and strengthen the fight against the pandemic in the region."
 
"The use of vaccine in prioritised populations, along with continued implementations of other public health measures and community participation will be important in reducing the impact of Covid-19," said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region.
 
This paves the way for the roll out of at least two vaccines in India in the coming days.
 
Meanwhile, Indian regulators stated that they are still considering approvals for other vaccines. One, made by Pfizer and BioNTech, has already been approved in the US and Europe. Another, Russia’s Sputnik V, appears to be less far along.



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